Improving HbA1c Levels by Methylcobalamin Vitamin in Diabetic Volunteers

Sponsor
Al-Balqa Applied University
Study ID
NCT06241638
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Vitamin B12 0.5 MG/ACTUAT — DRUG
    The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group. The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.
  • Dapagliflozin 10mg Tab — DRUG
    The investigators measured the blood levels of Vitamin B12 and HbA1c as well as the BMI in two study groups; The Experimental group: Vitamin B12 and Dapagliflozin group and Active Comparator group: Dapagliflozin group. The Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months, whereas, the Vitamin B12 and Dapagliflozin group received Vit. B12 supplements methylcobalamin 500 µg once daily orally with the anti-diabetic therapy Dapagliflozin 10 mg/daily orally for twelve months.

Study Details

The current study was conducted to evaluate the prognostic implications of vitamin B12 admission on BMI and HbA1c levels in type 2 diabetic patients treated with Dapagliflozin as a routine medication.

Key Dates

Start date
Jul 1, 2022
Status verified
Jan 2024
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Dapagliflozin group
    Dapagliflozin group received only Dapagliflozin 10 mg/daily orally for twelve months
  • Experimental: Vitamin B12 and Dapagliflozin group
    Vitamin B12 and Dapagliflozin group received orally Vit. B12 supplements methylcobalamin 500 µg once daily with their usual anti-diabetic therapy Dapagliflozin 10 mg/daily for twelve months.

Primary Outcome Measure

HbA1c in the two groups [ Time Frame: One year ]

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